NCT04595136

Brief Summary

Determine the efficacy and safety of COVID19-0001-USR in the treatment of SARS-COV-2 infection in mild to moderate manifestations administered via nebulization/inhalation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

October 15, 2020

Last Update Submit

May 21, 2021

Conditions

SARS-CoV-2 Infection

Keywords

Coronavirus InfectionsCOVID-19SARS-COV-2

Outcome Measures

Primary Outcomes (1)

  • Change on viral load results from baseline after using COVID19-0001-USR via nebulization

    COVID19-0001-USR 1% nebulized pathway changes viral load of SARS-COV-2 virus (COVID19) in the upper and lower airways if started during the initial phase of infection

    Treatment Period of 7 days

Study Arms (2)

COVID19-0001-USR

EXPERIMENTAL

Group 1 Patients with SARS-COV-2 (COVID19) positive test will receive Investigational Drug administer by nebulization ( COVID-19-0001-USR) Dosage: 3ml Frequency and Duration: Three times a day for 7 days

Drug: Drug COVID19-0001-USR

Normal Saline

PLACEBO COMPARATOR

Group 2 of patients with positive tests intervention SARS-COV-2 (COVID19) with placebo (i.e., normal saline 0.9% NS) plus standard baseline treatment for covid provided by Primary care provider ( Azithromycin, dexamethasone, and/or anticoagulants) Dosage: 3ml Frequency and Duration: Three times a day for 7 days

Drug: normal saline

Interventions

Drug COVID19-0001-USRDRUG

COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2

Also known as: Nebulized
COVID19-0001-USR
normal salineDRUG

0.9% NS via nebulization

Also known as: 0.9% NS
Normal Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide written consent before being included in the essay.
  • Positive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2),
  • Being diagnosed with mild to moderate SARS-COV-2 disease (COVID19)
  • Symptomatic or asymptomatic patient, with good clinical appearance, Sat O2 at rest \> 94% with room air, and without desaturation with ambulation, and without tachypnea,
  • Respiratory rate \< 20.
  • Suspected cases of COVID-19, based on 3 criteria:
  • Fever \> 38 Degrees Celsius
  • O2 saturation ≤94
  • Abnormal laboratory indicators, any of them:
  • Lymphopenia \<1500 cells/m3
  • C reactive protein \>2 mg/L
  • Ferritin \>300g/L

You may not qualify if:

  • Existing decompensated conditions such as Diabetes Mellitus, Hypertension, Coronary Insufficiency, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease (or any chronic or severe lung disease), Chronic Kidney Disease, Cancer, Immunosuppression, Mood Change
  • Respiratory Frequency \> 20 / min, Pulse \> 120 bpm, systolic \< 90 mmHg, diastolic \< 60 mmHg
  • The patient seems toxic and distressed, or, O2 at rest \<93% in ambient air, or desaturation when ambulating
  • Being diagnosed with severe SARS-COV-2 disease (COVID19)
  • Patients with low oxygen saturation levels, need for ICU entry, need or likelihood of invasive mechanical ventilation
  • Patients requiring bronchodilator treatment
  • Patients with a known history of asthma and/or lung disease
  • Patients with severe decompensated Chronic Obstructive Pulmonary Disease
  • Patients who are unable to give consent or who are unable to follow up on the test group will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cimedical

Barranquilla, Atlántico, Colombia

RECRUITING

Related Publications (9)

  • Pena-Silva R, Duffull SB, Steer AC, Jaramillo-Rincon SX, Gwee A, Zhu X. Pharmacokinetic considerations on the repurposing of ivermectin for treatment of COVID-19. Br J Clin Pharmacol. 2021 Mar;87(3):1589-1590. doi: 10.1111/bcp.14476. Epub 2020 Jul 17. No abstract available.

    PMID: 32779815BACKGROUND

  • Chan JF, Yip CC, To KK, Tang TH, Wong SC, Leung KH, Fung AY, Ng AC, Zou Z, Tsoi HW, Choi GK, Tam AR, Cheng VC, Chan KH, Tsang OT, Yuen KY. Improved Molecular Diagnosis of COVID-19 by the Novel, Highly Sensitive and Specific COVID-19-RdRp/Hel Real-Time Reverse Transcription-PCR Assay Validated In Vitro and with Clinical Specimens. J Clin Microbiol. 2020 Apr 23;58(5):e00310-20. doi: 10.1128/JCM.00310-20. Print 2020 Apr 23.

    PMID: 32132196BACKGROUND

  • Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.

    PMID: 32074444BACKGROUND

  • Zheng S, Fan J, Yu F, Feng B, Lou B, Zou Q, Xie G, Lin S, Wang R, Yang X, Chen W, Wang Q, Zhang D, Liu Y, Gong R, Ma Z, Lu S, Xiao Y, Gu Y, Zhang J, Yao H, Xu K, Lu X, Wei G, Zhou J, Fang Q, Cai H, Qiu Y, Sheng J, Chen Y, Liang T. Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: retrospective cohort study. BMJ. 2020 Apr 21;369:m1443. doi: 10.1136/bmj.m1443.

    PMID: 32317267BACKGROUND

  • Mitja O, Clotet B. Use of antiviral drugs to reduce COVID-19 transmission. Lancet Glob Health. 2020 May;8(5):e639-e640. doi: 10.1016/S2214-109X(20)30114-5. Epub 2020 Mar 19. No abstract available.

    PMID: 32199468BACKGROUND

  • Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.

    PMID: 32221519BACKGROUND

  • Wagstaff KM, Sivakumaran H, Heaton SM, Harrich D, Jans DA. Ivermectin is a specific inhibitor of importin alpha/beta-mediated nuclear import able to inhibit replication of HIV-1 and dengue virus. Biochem J. 2012 May 1;443(3):851-6. doi: 10.1042/BJ20120150.

    PMID: 22417684BACKGROUND

  • Mastrangelo E, Pezzullo M, De Burghgraeve T, Kaptein S, Pastorino B, Dallmeier K, de Lamballerie X, Neyts J, Hanson AM, Frick DN, Bolognesi M, Milani M. Ivermectin is a potent inhibitor of flavivirus replication specifically targeting NS3 helicase activity: new prospects for an old drug. J Antimicrob Chemother. 2012 Aug;67(8):1884-94. doi: 10.1093/jac/dks147. Epub 2012 Apr 25.

    PMID: 22535622BACKGROUND

  • Yang SNY, Atkinson SC, Wang C, Lee A, Bogoyevitch MA, Borg NA, Jans DA. The broad spectrum antiviral ivermectin targets the host nuclear transport importin alpha/beta1 heterodimer. Antiviral Res. 2020 May;177:104760. doi: 10.1016/j.antiviral.2020.104760. Epub 2020 Mar 3.

    PMID: 32135219BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Juan Jaller, MD

    United Medical Specialties

    PRINCIPAL INVESTIGATOR

  • Carlos A Riveros, MD

    United Medical Specialties

    STUDY DIRECTOR

Central Study Contacts

Carlos A Riveros, MD

CONTACT

305-224-2201Carlosrivg@gmail.com

Juan Jaller, MD

CONTACT

57-310-630-3530juanjaller@cimedical.co

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The mapping sequence will be hidden from the researcher by enrolling and evaluating participants in sequentially numbered, sealed, and stapled envelopes. To avoid the subversion of the allocation sequence, the name and date of birth of the participant will be written in the envelope, a second researcher verifies the process. The corresponding envelopes will be opened only after the enrolled participants complete all the reference assessments and assignment of the intervention by the protocol
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional study, randomized controlled, double-blind (i.e., active and passive control), 1 intervention group with investigative medicine, and a control group that will receive placebo intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 20, 2020

Study Start

November 2, 2020

Primary Completion

July 30, 2021

Study Completion

August 30, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)